Trial Initiative for Streamlining Review Procedures for Moderate Changes in Pharmaceutical Manufacturing

The document outlines a trial for implementing change procedures for moderate changes in pharmaceutical manufacturing methods. The trial aims to expedite the review process for moderate risk changes, with an emphasis on voluntary participation and faster review timelines.

Key details include:

• Scope: Changes in manufacturing methods, specifications, test methods, storage methods, and validity periods for ethical drugs.
• Process:
  1. Identify the change target
  2. Submit an application for approval
  3. Complete a conformity document survey
• Application Limit: A maximum of 15 applications per month, on a first-come, first-served basis.
• Exclusion: The trial does not include the Post-Approval Change Management Protocol (PACMP).

Source: https://www.mhlw.go.jp/hourei/doc/tsuchi/T240927I0010.pdf

Region: Japan